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NCT03502733 · ClinicalTrials.gov registry record · Phase 1
Testing the Combination of Copanlisib, Nivolumab and Ipilimumab in Patients With Advanced Cancer and Lymphoma
A Phase 1 study of Lymphoma and Metastatic Malignant Solid Neoplasm, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 1
- Development phase
- 64
- Enrollment target
- 3
- Study locations
NCT03502733: Active Phase 1 study of Lymphoma and Metastatic Malignant Solid Neoplasm, sponsored by National Cancer Institute (NCI).
NCT03502733 is a Phase 1 study of Lymphoma and Metastatic Malignant Solid Neoplasm that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 64 participants, below the 484-participant average among 299 other Lymphoma trials with a reported enrollment target (87% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03502733, a Phase 1 study of Lymphoma and Metastatic Malignant Solid Neoplasm, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 64 participants
- Enrollment target
- 3
- Study locations
Study Summary
This phase Ib trial studies the side effects and best dose of copanlisib and nivolumab and side effects of copanlisib given together with nivolumab and ipilimumab in treating patients with solid tumors that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or lymphoma. Copanlisib stops tumors from growing by blocking proteins that are known to be important for tumor cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving copanlisib together with nivolumab or with nivolumab and ipilimumab may work better in treating patients with solid tumors or lymphoma.
Primary Outcome
Will be defined as dose limiting toxicity in =\< 1 out of 6 patients at highest dose level below the maximally administered dose.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Biopsy Procedure
- PROCEDURE Echocardiography Test
- DRUG Copanlisib
Study Locations (3)
Maryland
- National Cancer Institute Developmental Therapeutics Clinic - Bethesda
- National Institutes of Health Clinical Center - Bethesda
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2018-08-14 |
| Est. Completion | 2026-07-01 |
| Phase | Phase 1 |
What the registry record for NCT03502733 still lists
NCT03502733 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 484-participant average among 299 other Lymphoma trials with a reported enrollment target (87% lower).
The record links to 4 conditions, with Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT03502733 reports a single indexed study location in Maryland, Texas.
Frequently Asked Questions
What is clinical trial NCT03502733 about?
NCT03502733 is a clinical study titled "Testing the Combination of Copanlisib, Nivolumab and Ipilimumab in Patients With Advanced Cancer and Lymphoma". This phase Ib trial studies the side effects and best dose of copanlisib and nivolumab and side effects of copanlisib given together with nivolumab and ipilimumab in treating patients with solid tumors that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts o...
What is the current status of trial NCT03502733?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 64 participants. The study started on 2018-08-14. Estimated completion is 2026-07-01.
What conditions does trial NCT03502733 study?
This clinical trial studies the following conditions: Lymphoma, Metastatic Malignant Solid Neoplasm, Recurrent Malignant Solid Neoplasm, Unresectable Malignant Solid Neoplasm.
What interventions are being tested in trial NCT03502733?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Biopsy Procedure (PROCEDURE), Echocardiography Test (PROCEDURE), Copanlisib (DRUG).
Who is sponsoring clinical trial NCT03502733?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03502733 being conducted?
This trial has 3 study locations across Maryland, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03502733's enrollment target sits among peer trials
64 124th of 299 higher than 176 of 299 other Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lymphoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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